BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    OneDraw A1C Test System

    FDA 510(k)
    FDA Class 2 ·Hematology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304438125·

    AGILE NAIL

    FDA UDI
    ORTHOFIX SRL·18054242518167·ENTRY REAMER GUIDE

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100981·DESMARRES LID RETRACTOR #3

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515028241·Balfour Abdominal Ret set, 10" spread, fixed bl...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A183230120·18mm H x 32mm W x 30mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A18323080·18mm H x 32mm W x 30mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A183230150·18mm H x 32mm W x 30mm L x 15 degrees ALIF

    MERCURY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOMET CC CRUCIATE TRAY 75MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 22, 2017

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 21, 2013

    FREESTYLE NAVIGATOR

    FDA Adverse Event
    Malfunction ·Product code LFR·July 28, 2011

    UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MOQ·October 17, 2014

    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

    FDA Enforcement
    Class III ·Terminated·Biomet, Inc.·June 17, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012